To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise to join my colleagues, particularly the gentleman from Arkansas (Mr. Boozman), in supporting this important bill to apply the highest safety standards and consumer protections to all contact lenses.

This legislation became necessary on April 4, 2003. On this date, the Food and Drug Administration decided to classify certain colored contact lenses as cosmetics, not medical devices. This classification made no sense. Cosmetics are not required to be made according to strict manufacturing standards; cosmetics are not reviewed for safety prior to marketing; and cosmetics are not prescribed by a doctor.

The loose regulatory approach to cosmetics may work for lipstick; but it is dangerous for contact lenses, which are placed directly on the eyes. If contact lenses are not made properly, they can cause severe infections. If lenses do not fit properly, they can cause disfiguring ulcers, and if lenses are worn by teenagers or others without the ongoing supervision of an eye care professional, severe injuries can result.

Since April 4, 2003, scores of teenagers and young adults have been injured by cosmetic contact lenses. Some have permanently lost vision. Others have required corneal transplants. In one survey in Louisiana, 85 percent of optometrists and 45 percent of ophthalmologists reported diagnosing eye injuries from contact lenses sold without a prescription.

Since April 4, 2003, I have worked with the gentleman from Arkansas (Mr. Boozman), contact lens manufacturers, the American Academy of Ophthalmology, the American Optometric Association, and consumer advocates to ensure that all contact lenses are regulated according to the strict standards and consumer protections applied to medical devices.

In the 108th Congress, our legislation passed the House, but not the Senate. In late July of this year, the legislative approach that we designed passed the Senate. It is this legislation that is again before the House.

By passing this bill, we can ensure the FDA protects consumers from unsafe contact lenses, we can prevent serious eye injuries, even blindness, and we can send a timely message to teenagers and their parents about the dangers of unsupervised use of contact lenses at Halloween.

I would like to express my appreciation to Senators DeWine and Kennedy for guiding this legislation through the Senate, I would like to thank those at FDA who supported our legislative solution, and I recognize the efforts of experts such as Thomas Steinemann in Cleveland, who worked hard to raise awareness about the availability and dangers of unsafe lenses.

I especially want to thank and congratulate our colleague, the gentleman from Arkansas (Mr. Boozman), for his persistence and hard work in the House of Representatives. I urge my colleagues to support this bipartisan consensus legislation today.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

I want to thank my colleague from Arkansas for his very kind words and join him in saluting all of the Members of the House and the Senate and our staffs who have worked on this legislation. I do not want to dwell on why the FDA decided to regulate some lenses as cosmetics rather than medical devices. Congressman Deal referred to it as a loophole. I consider it a lapse in enforcement. Regardless, this bill is neutral on what went wrong. It just fixes the problem, and that is what we need to do. I would urge all of our colleagues to join us in supporting the legislation.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, last Congress, myself, Mr. Waxman in the House, Senator DeWine, Senator Kennedy in the Senate, became aware of a very serious problem. The FDA had claimed jurisdiction over all contact lenses, and then in April of 2003 announced that it did not feel like it had jurisdiction over contact lenses that did not have any power in them anymore. In other words, there were lenses that were sold for the purpose of changing eye color, sold at Halloween to enhance; if you were going to a whatever and wanted to look kind of wild, you could buy these lenses. Up until then, everyone agreed that a contact was a contact, but when they got to looking at their statute, they were very concerned that they did not have any jurisdiction.

As a result, these lenses began being sold at flea markets, began being sold at places where you get your nails done, and when they were sold, no one told them how to put them in and take them out, there was no effort at all to teach anything about hygiene, the disinfecting solutions that you needed to prevent your eyes from becoming infected.

Dr. Steineman at Case Western Reserve about this time started seeing a tremendous incidence in eye infections related to these lenses. Let me just tell my colleagues about a couple of them. Here is an example of a young gal that was 16 years old. Her boyfriend supplied her with these colored contact lenses, did not have any power in them, so they were not regulated. The patient admitted to sharing the colored contact lenses with her younger brother, again doing this because she had no idea of how you take care of this type of situation.

You say, well, it is just a 16-year-old. Here is an example of a 26- year-old that also bought contact lenses at a flea market that made him have cat eyes. This individual developed a very significant, very severe infection, which probably resulted in loss of vision.

Today what we are trying to do by passing this bill is to close the loophole which everybody agrees needs to be done. So the real heroes of this have been the FDA. We have worked very, very hard with them and have gotten language that they have agreed to; Dr. Steineman, in doing the early work in identifying this; and ophthalmology, optometry that have really pressed the issue in the House; the manufacturers of the particular lenses; Senator DeWine and Senator Kennedy in the Senate; and then also Mike Enzi, the chairman of the committee over there that really took this upon himself to get this thing passed. Mr. Waxman has done a tremendous job of working with us and just really going through in an effort to get the particular language that would get this done without affecting the jurisdiction of the FDA. So I really appreciate the gentleman from California; also, Chairman Barton and Chairman Deal in allowing this to go forward to get this to the floor. These were the guys that really allowed us to get this done. We had a goal of getting this done before Halloween, and I think we are almost there.

The other thing I would like to do, which needs to be done more than we do it, is thank our staffs. They have

put in literally countless hours trying to get this thing worked out.

Again, I would urge all of my colleagues to support this bill. I think it is something that needs to be done, and it is one of those things that as a result of us getting this done today truly will protect our youth, protect people in keeping them from experiencing a devastating eye injury.

I also want to thank the majority leader, Mr. Blunt, for getting this scheduled, again before Halloween.

Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 172) to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on S. 172.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I am proud to rise in favor of S. 172, and I would like to thank the gentleman from Arkansas (Mr. Boozman) and the gentleman from California (Mr. Waxman) for their work on the House companion bill, which was H.R. 371.

Historically, the contact lens industry in the United States has secured prior approval from or clearance by the Food and Drug Administration prior to the introduction of contact lenses into the United States market. These same contact lens manufacturers also have been subjected to and complied with numerous requirements codified in the Federal Food, Drug, and Cosmetic Act.

A few companies challenged the FDA's ability to regulate non- corrective decorative contact lenses as medical devices to create a loophole in the current law. As a result, these entities distribute their products without the attendant controls that historically have safeguarded contact lens consumers.

The uncontrolled distribution of decorative contact lenses has caused a variety of eye injuries and conditions. At first, what might seem to be a minor irritation, if left untreated, can develop permanent eye damage and loss of vision. S. 172 would close this loophole by restoring the FDA's ability to regulate all contact lenses as medical devices.

Mr. Speaker, I urge Members to support this legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I am pleased to yield such time as he may consume to the gentleman from Arkansas (Mr. Boozman), who is the original cosponsor of the House companion bill to this legislation.

Mr. Speaker, I have no further requests for time, I urge the adoption of this Senate bill, and I yield back the balance of my time.